‘Trust’ in vaccines

National Task Force (NTF) chief implementer Secretary Carlito Galvez Jr. flew last night to India along with several other Philippine government officials to conduct an ocular inspection of a vaccine manufacturing facility owned and operated by Serum Institute of India (SII). As the designated “vaccine czar,” Galvez is taking extra miles to conduct “due diligence” in the procurement of 30 million doses of Covavax, a vaccine brand against the 2019 coronavirus disease (COVID-19) causing deaths of pandemic proportions.

Galvez was joined in this trip by representatives from at least five government agencies, namely, the Department of Health (DOH); the Food and Drug Administration (FDA); the Department of Finance (DOF); the Vaccine Experts Panel from the Department of Science and Technology (DOST); and another from the NTF. The three-day visit will take them to the city of Puna in India where the SII has its Novavax vaccine manufacturing plant producing Covavax.

A day before they left for India, Galvez expressed the hope he would be able to finalize and sign the supply agreement for the Philippines of 30 million doses of SII’s Covavax for delivery this year. The City of Puna – the site of the Novavax manufacturing plant – was placed in lockdown by Indian government two weeks ago following upsurge of COVID-19 cases in that area. The previously scheduled trip there of Galvez was consequently postponed.

If this agreement is sealed, Novavax will become the third American anti-COVID vaccine supplier here. It will be available along side with Pfizer and Moderna also slated for delivery this year.

The SII is billed as the world’s largest vaccine producer. Novavax, on the other hand, is a biotech American company based in Maryland in United States (US) that has a joint project with SII to manufacture Covavax. This is because not one manufacturing facility can supply vaccines. This we have seen in the current COVID-19 contagion. Pharma companies, other vaccine manufacturers and cold chain storage distributors across the world have forged alliances, especially in the production of vaccines to control pandemic.

Incidentally, the SII also manufactures the anti-COVID vaccines developed by the University of Oxford- AstraZeneca for the South Asia market of SII. “We might also have other supply agreements for the AstraZeneca and Covishield that the government will buy from the Serum Institute of India,” Galvez disclosed on the eve of his departure in Manila. The Philippines earlier received 500,000 doses of AstraZeneca COVID-19 vaccines from the World Health Organization (WHO)-led COVAX facility.

Although this was a direct supply agreement for the procurement of Novavax, this will be handled for the Philippines by Faberco Life Sciences Inc. Faberco is partner of SII for low and middle-income countries. It is the authorized representative of SII here in our country.

Faberco signed in January this year an agreement with our own local pharmaceutical giant Unilab Inc. to make Covavax vaccine available to workers and employees in the private sector. Faberco designated Unilab as its authorized partner for the private sector in the Philippines. On the other hand, Faberco will be the one to handle direct negotiations with the national government and the local government units (LGUs) in our country’s procurement of the Covavax.

Once the supply deal is signed, the vaccine doses of Covavax will be made available especially to hospitals and essential industries in the private sector, with the condition that they be made available at no cost to their employees. And depending on the company’s financial capability, the Covavax vaccines will also be available to the employees’ families and the selected communities in the private sector.

Further, the distribution and administration of the vaccine will be strictly subject to the guidelines set forth by the DOH, including those pertaining to “pharmacovigilance.”

Jose Maria A. Ochave, senior vice president for Social Partnerships of Unilab described their partnership agreement with Faberco as not a commercial transaction. “This initiative is not for a business purpose but to help the country secure more vaccine allocations,” Ochave cited.

“So we’re hoping with this partnership with Faberco will lead to a lot of other products we can bring in from Faberco and SII,” Ochave admitted during our Zoom Webinar of Kapihan sa Manila Bay last week.

Ochave believes the on-site inspection trip that Galvez-led delegation to India will facilitate the early approval of Covavax of its emergency use application (EUA). This is currently under the evaluation by the Philippine Vaccine Expert Panel and our own FDA. “It’s very prudent and it’s the right thing to do. For that, we commend Sec.Galvez,” Ochave cited.

“The commitment is the vaccines should be on the ground by July,” Ochave revealed. “Of course, we’re working for earlier one except it will be limited by volume, for government getting 30 million (doses),” he added.

Ochave likened the inspection trip to the “audit of facility” that they normally do in the pharma industry must conduct. This, he explained, is “part of due diligence,” especially involving procurement of not just vaccines but also other medicines and health products.

“In the world of pharma, trust is very, very important,” the Unilab executive stressed.

Although the SII have “WHO-certified facility,” Ochave underscored, everything still has to be checked, including documentation, the integrity of documents, and even the protocols on who can enter the facility. “That’s why the government is visiting the facility this month in order for the scientists and the regulators to check the facility,” he pointed out.

Ochave believes the Covavax maybe able to get its EAU approval within this month from the FDA of the United Kingdom (UK). By May this year, he cited, the EAU application of Covavax will be submitted to the FDA of US.

So this next anti-COVID vaccine to come soon should fit to a T, or “trust” required by people to get inoculated.